510(k) K971395

GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE by Target Therapeutics — Product Code DQX

K971395 is an FDA 510(k) premarket notification submitted by Target Therapeutics for the device "GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE". The FDA issued a decision of Substantially Equivalent on July 14, 1997. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Target Therapeutics has at least 10 other 510(k) clearances on record.